The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Pediatric Arterial Blood Filter.
Device ID | K810068 |
510k Number | K810068 |
Device Name: | PEDIATRIC ARTERIAL BLOOD FILTER |
Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
Applicant | DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTM |
CFR Regulation Number | 870.4260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-13 |
Decision Date | 1981-01-22 |